Kornimate/medical-research-clean huggingface dataset:
influence of valproic acid on extinction-based therapy in patients with fear of spiders.

Conditions: Phobia, Specific

Summary: the purpose of this study is to evaluate whether valproic acid in combination with fear memory reactivation is useful to enhance treatment stability of exposure therapy for specific phobia.

* there will be one screening visit (visit 1), one intervention visit (visit 2) and one follow-up visit (90 days after visit 2) (visit 3). * on visit 2 all participants will undergo 30 min exposure therapy in virtual reality with pre-defined spider situations. * duration for an individual participant will be at most 15 weeks depending on the time passing between screening (visit 1) and intervention visit (visit 2). * change in phobic fear to baseline (visit 1) will be assessed on 90 day follow-up (visit 3). * documentation of all study relevant source data of every study participant will be done by completing the study specific electronic case report forms (ecrf, sosci survey) and study specific case report forms on paper (adverse events, serious adverse events and concomitant medication). data in the ecrf can be validated for completeness and discrepancies automatically. an audit trail system maintains a record of initial entries and changes (reasons for changes, time and date of changes, user identification of entry and changes). * quality insurance will be done by an external site monitoring (including study progress, accuracy and completeness of ecrf, fulfillment of protocol requirements, applicable local authority regulations and investigator's obligations). * monitoring includes 100% of safety parameters, primary endpoints, informed consent documents and the trial master file on the initiation visit and on close out. * standard operating procedures to address study activities such as patient recruitment, informed consent, study interventions, data collection, data management, data analysis, and reporting for adverse events exist.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of specific phobia (animal type: spider) * bat score (at screening) between 1 and 7 points * physically healthy * normotensive (90/60-140/90 mmhg) * male or female * aged between 18 and 40 years * native or fluent german-speaking * females have to be on effective birth control exclusion criteria: * other axis i disorder except a further comorbid phobic disorder * concurrent psychotherapy or pharmacotherapy * previous exposure-based therapy for specific phobia * parallel participation in another study * body weight less than 50kg * long-term medication intake * substance abuse * 5 or more cigarettes a day and/or inability of being abstinent for at least 5 hours * pregnancy or breast-feeding * kinetosis * history of coagulation disease * history of gastrointestinal disease * laboratory exclusion criteria: clinically relevant deviation of laboratory values (blood count, blood chemistry, coagulation status, liver and pancreas enzymes, electrolytes) from normal range
study to evaluate medi-507 in patients with cd2-positive lymphoma/leukemia

Conditions: Lymphoma; Leukemia; Cancer

Summary: for primary objectives, we will determine the mtd and examine clinical responses and immune cell populations to determine an obd, and describe the safety and tolerability of medi-507. for the secondary objectives we will look at the antitumor activity of medi 507, pk, serum concentrations, and immunogenicity of medi-507, as well as time courses of depletion and recovery of cd2 positive and total t-cell populations.


Eligibility criteria:
individuals may be eligible for this study if they are 18 years of age or older and: * have one of the following types of t-cell lymphoproliferative disorders such as cutaneous t-cell lymphoma (ctcl), peripheral t-cell lymphoma (pctl), large cell lymphoma (lgl), or adult t-cell lymphoma (atl). patients should have disease that is resistant or refractory to the front-line therapy, except atl patients for whom there is no standard therapy. * at least 30% of tumor cells must be cd2 positive. * karnofsky performance status of greater than or equal to 70% (able to care for themselves; but unable to carry on normal activity or to do active work). * at least 3 weeks must have passed since prior systemic cytotoxic chemotherapy, prolonged or cytolytic steroid therapy or major surgery, and all treatment-related toxicities must have resolved prior to the first medi-507 administration (except thrombocytopenia). * have no prior treatment with medi-507.
the effects of treatment with naltrexone in alcohol and cannabis-dependent patients

Conditions: Alcohol-dependence

Summary: alcohol dependence is a major health problem worldwide and recently in israel and it has major health care costs. cannabis dependence is also a major health issue and many cannabis users find it difficult to quit. similar to dependence on heavy drugs, alcohol and cannabis-dependent patients find it difficult to quit drinking and smoking cannabis and they relapse to drinking alcohol and using cannabis during treatment. craving for alcohol and cannabis and withdrawal during detoxification are major factors for relapse to drinking and using cannabis. the cue-exposure and priming paradigms have been used in order to induce craving for alcohol and cannabis in the laboratory. several studies have delineated the brain mechanisms responsible for cue-induced craving for alcohol using functional magnetic resonance imaging (fmri), a method that can be useful in monitoring progress of treatment. a proven useful medication for treatment of alcohol dependence is the opiate antagonist naltrexone commonly used for treatment of opiate dependence. we have found that cannabis-dependent patients in treatment for cannabis dependence who also were heavy users of alcohol have dropped early from treatment.

we propose to use naltexone to reduce craving for alcohol and cannabis in alcohol and cannabis-dependent patients. we also propose to use established techniques of priming and cue-exposure for alcoholic drinks and cannabis together with measures of \[18f\] fluorodeoxyglucose (fdg) in positron emission tomography (pet) imaging in 24 alcohol and cannabis-dependent patients before and after 35 day treatment with naltrexone. we predict that in those who will be successful in quitting alcohol drinking and using cannabis there would be a reduction in alcohol and cannabis cue-induced brain activity in the meso-limbic reward circuit that is responsible for craving for alcohol and cannabis.

Eligibility criteria:
inclusion criteria: * alcohol dependent patients both males and females age 22-64 exclusion criteria: * subjects who are diagnosed as suffering from psychotic illness according to dsm-iv (axis 1) (american psychiatric association, 1994) or with a history of cns disease, a history of infection that might affect cns (hiv, syphilis, cytomegalovirus, herpes), a history of head injury with loss of consciousness, history of other substance abuse taking psychoactive medications (shown by urine test). abnormal liver test results (150% above average) will be excluded. pregnancy is also an exclusion criterion, as radiation exposure is risky for the fetus.

Keywords: alcohol naltrexone cue reactivity pet
attr amyloidosis in elderly patients with aortic stenosis

Conditions: Aortic Stenosis Symptomatic; Amyloidosis Cardiac

Summary: severe aortic stenosis is defined with a mean transvalvular pressure gradient (mtpg) \> 40mmhg and a calculated aortic valve area of \ 50%). this entity is termed paradoxical low flow low gradient aortic stenosis (plflg as) and is associated with a worse prognosis. attr amyloidosis is a disease of the elderly and might coexist in patients with severe aortic stenosis. case reports and small observational studies suggest that senile attr amyloidosis could be frequent but underdiagnosed in patients with aortic stenosis. there is significant overlap between plflg as and cardiac amyloidosis with regard to symptoms, increasing prevalence with age, concentric hypertrophy, impaired diastolic filling of the left ventricle (lv), as well as longitudinal lv dysfunction despite preserved ejection fraction - all features, which lead to a reduction in stroke volume, the underlying mechanism of the low flow condition as observed in plflg as patients.


Eligibility criteria:
inclusion criteria: * symptomatic, severe aortic stenosis exclusion criteria: * more than mild valvular disease of any other valve * other severe disease with a life expectancy \< 1 year * participating in trial interfering with routine clinical practice or use of a non-ce marked device
the effect of soluble epoxide hydrolase (seh) on depression

Conditions: Major Depressive Disorder

Summary: depression is the most common mental disease and the second leading cause of chronic disease burden, which is closely related to suicidal behavior. the diagnosis and treatment of depression still lack of effective biological indicators, and about 30% of patients with depression still can not relieve their depressive symptoms after treatment. previous studies have found that atp release from astrocytes plays an important role in the occurrence, development and treatment of depression. epoxy eicosotrienes (eets) are closely related to the function of the nervous system and may be the pathophysiological mechanism of depression. soluble epoxide hydrolase (seh) can regulate atp release by affecting eet degradation, leading to depression like behavior and antidepressant effect, and seh is closely related to cognitive function of depression.

this study is an observational study without any intervention treatment for the subjects. all subjects need to sign the informed consent before screening, and the successful subjects can enter the study. routine clinical diagnosis and treatment were performed on patients with depression, and the treatment effect of depressive symptoms, neurocognitive function and suicide improvement were evaluated at the 2nd week, 1st, 2nd, 3rd, 6th and 12th months after enrollment, and statistical analysis was conducted. the treatment lasted until the subjects completed the 12th month follow-up or reached any of the withdrawal criteria. this study will clarify the relationship between seh gene polymorphism and mrna expression and depression and suicide behavior, and explore the predictive role of soluble epoxide hydrolase seh in the treatment effect of depression, cognition and suicide improvement during the follow-up study.

Eligibility criteria:
* inclusion criteria: 1. voluntarily sign informed consent; 2. age: 18-65 years old; 3. elementary school or above, able to understand and complete all inspections and assessments; 4. did not take any psychotropic drugs (including benzodiazepines) within 2 weeks before enrollment; 5. after routine medical diagnosis by clinicians, they were divided into depression and healthy people. * exclusion criteria: 1. severe somatic or neurological diseases; 2. mental retardation and dementia; 3. during pregnancy or breastfeeding; 4. heavy smoking, alcoholism and other substance abuse or dependence (within 3 months before enrollment); 5. electric shock treatment (within 3 months before enrollment); 6. according to the judgment of the investigator, it is not suitable to participate in this study.

Keywords: depression cognition suicide soluble epoxide hydrolase，seh prediction
determining the impact of a new physiotherapist-led primary care model for low back pain

Conditions: Back Pain, Low

Summary: this is a cluster randomized controlled trial to to evaluate the individual and health system impacts of implementing a new physiotherapist-led primary care model for back pain in canada.

this study aims to evaluate the individual health outcomes and health system impacts of implementing a new physiotherapist-led primary care model for people with low back pain (lbp). the overarching goal of this study is to determine the impact of integrating a physiotherapist (pt) within primary care teams for people with lbp and making them available to patients as the first point of contact. the specific aims of the research are to determine: 1. whether a pt-led primary care model for lbp is effective at improving function (primary outcome), pain intensity, quality of life, global rating of change, and adverse events in comparison to usual physician led primary care. 2. the impact of a pt led primary care model for lbp on the healthcare system and society (healthcare access, primary care physician workload, healthcare utilization, missed work, and cost-effectiveness). a process evaluation will assess the healthcare delivered, potential mechanisms, context of implementation, and perspectives of patients and primary care providers towards the pt-led primary care model.

Eligibility criteria:
inclusion criteria: * adults (19 years and over) with low back pain of any duration who are seeking primary care for back pain at a participating site (primary care visit may be a first or repeat visit). exclusion criteria: * patients who do not consent to participation * patients who report being unable to understand, read, and write english * patients for whom the cause of their back pain is cancer
hud: pip joint implant

Conditions: Arthrosis; Osteoarthrosis

Summary: this surgery involves the use of a finger joint replacement device for treatment of patients with certain kinds of arthritis (osteo - arthritis or post traumatic arthritis) and who expect to place their hands in heavy loading situations, or patients needing revision of a failed implant placed in the pip joint. a joint replacement surgery is an operation where the arthritic joint is removed and a metal and plastic joint is inserted to replace the natural joint. the surgery is expected to last about 2 hours. the procedure is done in the operating room and requires general anesthesia or an axillary block. (general anesthesia affects the entire body and is accompanied by a loss of consciousness. an axillary block results in anesthesia of the hand and forearm only. a tourniquet is applied to the arm to prevent bleeding during the surgery.)


Eligibility criteria:
inclusion criteria: * patients with disability of the their finger from arthrosis exclusion criteria: -

Keywords: proximal interphalangeal joint deformity arthroplasty
radioactive stents for treatment of unresectable biliary tract cancer

Conditions: Intrahepatic Cholangiocarcinoma; Cholangiocarcinoma of the Extrahepatic Bile Duct; Ampullary Carcinoma; Biliary Obstruction

Summary: the purpose of this study is to determine whether radioactive stents and common used plastic stents are effective and safety in the treatment of unresectable biliary tract cancer.

patients with unresectable biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, or ampullary carcinoma) were enrolled and placed with a stent loaded with radioactive seeds (irradiation stent group) or a conventional plastic stent (traditional stent group). after stent placement, the outcomes were compared in terms of tumor response, progression-free survival, overall survival time, and complications related to the procedures.

Eligibility criteria:
inclusion criteria: * patients were eligible if they had received a histopathological or cytologic diagnosis of nonresectable, recurrent, or metastatic biliary tract carcinoma (intrahepatic or extrahepatic cholangiocarcinoma,or ampullary carcinoma) * patients aged between 18 and 80 years * an estimated life expectancy of more than 3 months * disease had to be measurable by computed tomography scan (as assessed by response evaluation criteria in solid tumors (recist) 1.0 criteria * tnm stage iii-iv * no evidence of cancer of another organ. * no prior chemotherapy for advanced disease was allowed, but adjuvant/neoadjuvant therapy was allowed * karnofsky index of ≥60% * ecog index ≥2 * previous technically successful stenting or enbd derange * accept of informed consent exclusion criteria: * clinically significant cardiovascular disease * coagulation disorders * contraindication of endoscopic * pregnant or breastfeeding women * known sensitivity sensitivity to investigated agents or components * recent invasive procedure * prior chemotherapy or radiotherapy for biliary cancer * refusal of informed consent

Keywords: radioactive stents brachytherapy biliary obstruction intrahepatic cholangiocarcinoma cholangiocarcinoma of the extrahepatic bile duct ampullary carcinoma
nurse managed sequential strength training and bicycle training in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this is a 16 week exercise training program for people with severe to very severe chronic obstructive pulmonary disease (copd). the purpose of this study is to find out if performing strength training prior to initiating exercise training on a stationary bicycle is associated with greater gains in functional status than bicycle training alone or concurrent bicycle and strength training together.

volunteers are randomly assigned to one of three groups: 1). 8 weeks of resistance (strength) training followed by 8 weeks of bicycle exercise training, 2). 8 weeks of chair exercise followed by 8 weeks of resistance (strength) training and bicycle exercise training, or 3). 8 weeks of chair exercise followed by 8 weeks of bicycle exercise training. the length of the training is 16 weeks for all 3 groups. volunteers train 3 days per week in our lab located in the chicagoland area and are supervised by an exercise specialist.

Eligibility criteria:
inclusion criteria: * fev1/fvc \< 70 and fev1 \< 55%, * \> 45 years of age, * experience dyspnea with exertion, * stable clinical condition (stable clinical condition is defined as free of respiratory tract infections for at least two months prior to enrollment, no recent change in the color, consistency, or quantity of sputum, afebrile and no recent change in medical therapy.) exclusion criteria: * evidence of restrictive lung disease or asthma, * acute respiratory infection, * taking oral corticosteroids on a regular basis, * \>3 exacerbations in the previous year, * currently participating in pulmonary rehabilitation, * the presence of a potentially debilitating disease or the presence of a condition that would make it potentially unsafe to exercise. * we will adhere to the american college of sports medicine guidelines and exclude those who do not meet their guidelines for exercise testing and training. * pregnant women or women who plan to become pregnant during the study.

Keywords: copd pulmonary rehabilitation resistance training aerobic training dyspnea
proteomics study of gastric bypass surgery to treat type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to reveal the key proteins involved in gastric bypassing surgery which may effect the decreased glucose in type 2 diabetes patietns, and evaluate standard remission rate as well as cost-benefit of gastric bypassing surgery for type 2 diabetes mellitus patients in china.

diabetes mellitus is a major global problem which responsibles for 4.6 million deaths each year without effective therapy methods. recently，researchers showed that type 2 diabetes mellitus can be partly reversed by gastric bypassing surgery. however, surgeons are still not clear how to chose the proper diabetes patients for surgery as the mechanism is still not clear, and the remission rate of diabetes mellitus is not the same among different surgical procedures. this study will enroll type 2 diabetes mellitus patients follwing roux-en-y gastric bypassing surgery and obese persons without type 2 diabetes surgery. the defferent expressions of serum proteins of obese persons without type 2 diabetes and type 2 diabetes patients following gastric bypassing surgery after 10 days or 3 months were detected by serum proteomics. blood samples and urine will be taken prior to surgery, 10 days after surgery and 3 months after surgery. the long term prognosis of diabetes mellitus for 1 years and the remission rate of diabetes of patients will be evaluated.

Eligibility criteria:
inclusion criteria: * patients diagnosed as type 2 diabetes are planning to have roux-en-y gastric bypass * age:18-65yr * hbalc\>8% exclusion criteria: * diabetes (applies for control patients) * chronic inflammatory disease * malignant disease * pregnancy * prior gastric, duodenal, proximal jejunal surgery or pancreas resection * current use of thiazolidinediones * treatment with incretin mimetics or dpp iv inhibitors in the prior 3 months * hbalc\<8% * any condition felt by the investigator to interfere with ability to complete the study

Keywords: gastric bypass surgery proteomics
value of amphotericin b inhalation for prophylaxis of invasive pulmonary aspergillosis after renal transplantation

Conditions: Invasive Pulmonary Aspergillosis

Summary: the purpose of this study is to determine whether inhalation with aerosolized amphoterin b 10mg/d is more effective than aerosolized amphoterin b 2mg/d to reduce the incidence of invasive pulmonary aspergillosis.


Eligibility criteria:
inclusion criteria: * 65ys≥age≥18ys * renal transplant recipients exclusion criteria: * subjects with hypersensitivity to amphotericin b * receipt of inhalational or intravenous amphotericin b within last 30 days * subjects with known invasive fungal infection before renal transplant * subjects with pneumonia
study to determine skin irritation potential of an antifungal cream containing trolamine after repeated skin application (cumulative irritation patch test)

Conditions: Hypersensitivity

Summary: in this study researchers want to study the potential skin reaction after repeated application of an antifungal cream containing trolamine. the study plans to enroll about 32 healthy female or male participants with the age 18 - 79 years. researchers will apply on the skin of the upper back between the shoulder blades of the study participants three different patches to cover a small amount of the antifungal cream or 0.3% solution of sodium lauryl sulfate, which is known to cause skin irritation (so called positive control). a third patch will cover a skin area without any product (so called negative control). participants will return daily to the study center to have new patches containing the test products applied on the same skin area of the back, excluding weekends, for 21 days of continuous skin contact. at each visit the skin will be investigated by the researchers for redness, dryness and other reactions to learn about the skin reaction after repeated application.


Eligibility criteria:
inclusion criteria: * participants must have been aged 18 to 79 years, inclusive. * participants must have understood and executed an informed consent form (icf). * participants (if female) must have been willing to take a urine pregnancy test prior to the initiation and at the completion of the trial. * participants must have been capable of understanding and following directions. * participants must have been considered reliable. exclusion criteria: * participants who were in ill health or taking medication, other than birth control, which could have influenced the purpose, integrity or outcome of the trial. * participants who had any visible skin disease that might have been confused with a skin reaction to the test material. * participants who were participating in another clinical trial at this facility or any other facility. * participants who were using topical or systemic steroids or antihistamines for at least 7 days prior to trial initiation and during the duration of the trial. * participants who had a history of adverse reaction to adhesive tape, cosmetics, over-the-counter (otc) drugs or other personal care products. * participants judged by the principal investigator (pi) to be inappropriate for the trial. * female participants who were pregnant as evidenced by a positive urine pregnancy test, planning to become pregnant, or nursing during the course of the trial.